Advertising of medical devices
As of 1st January 2019, advertising of medical devices must comply with the latest revision of the Therapeutic Goods Advertising Code (the Code). The TGA has issued guidelines, the Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG), to assist sponsors to maintain compliance with the Code.
In today’s interconnected world consumers expect to be able to access information quickly and easily. MTAA advocates for implementation methods that achieve compliance in a manageable and sustainable manner. MTAA submissions to consultations are available here: [link to Regulatory > Current Issues > Submissions – for members only]
Under the Therapeutic Goods Act 1989, it is prohibited and is an offence to advertise to any person a medical device that is not included on the ARTG. Unapproved devices (i.e., not included in the ARTG) may, under certain conditions, be accessed legally via the clinical trial pathway, the Special Access Scheme (SAS), the Authorised Prescribers (AP) or the personal import scheme. A company or a person may claim that they can arrange the supply of an unapproved medical device provided the unapproved device is supplied legally. Note that ‘advertising’, as defined in the Therapeutic Goods Advertising Code 2018, is not the same as making ‘claims about arranging supplies of medical devices’.
Promotional material is a form of advertising. Even if the material or the format of advertising can be said to promote the use or supply of relevant goods only in an indirect way, the material or format will still be an 'advertisement'. Also, unsolicited information is more likely to be considered promotional. Digital communications channels such as social networking sites, blogs and discussion forums when these are used to promote therapeutic goods must comply with the Therapeutic Goods Advertising Code 2018 as well.
Advertising of health services involving medical devices including IVDs is also subject to restrictions. An advertisement to the general public for a health service that specifies (whether directly or indirectly) the use of therapeutic goods would be likely to promote the therapeutic goods concerned. Such health service advertisements must therefore comply with the Australian therapeutic goods advertising legislation. There are some provisions of the therapeutic goods advertising legislation that also apply to advertising to health professionals.
We encourage sponsors to visit TGA’s portal Advertising hub. The advertising hub brings together news and information about the regulation of therapeutic goods advertising. It contains tools for both consumers and advertisers, including fact sheets, e-learning modules and forms for reporting illegal advertising and submitting enquiries. It also provides information about the changes to the framework for advertising therapeutic goods that are being implemented between 2018 and 2020.